Effect of Salt Restriction on Renin Activation

NCT01628302 | Completed

• 1 other identifier: HT-Salt
• Study Type: interventional
• Target: 28
• Locations: 0 countries
• Sites: N/A

Brief Summary

The present prospective, randomized, crossover study is designed to investigate the effect of salt consumption on blood pressure in hypertensive subjects. Secondary objectives of the study are to evaluate the effect of salt consumption on blood pressure among the subjects who are hypertensive and obese and normal according to body mass index and to evaluate the effect of salt consumption on renin activity in hypertensive subjects.

Conditions

Hypertension

Keywords

Hypertension,plasma renin activity,salt consumption

Outcome Measures

Primary Outcomes (1)

• Change from baseline in 24-hour ambulatory blood pressure at 3 weeks

  24-hour ambulatory blood pressure was measured before the beginning of diet specific to their groups, at the end of the 3-week diet, before the beginning of the second diet and at the end of their second diet.

  3 weeks

Secondary Outcomes (8)

• Change in sodium levels in urine samples.

  3 weeks

• Change in plasma renin activity

  For 3 times in 8 weeks

• Change in aldosterone level in blood samples

  For 3 times in 8 weeks

• Change in potassium levels in urine samples.

  3 weeks

• Change in urea level in urine samples

  3 weeks

Study Arms (2)

Normal salt diet

NO INTERVENTION

The group had normal salt diet (250mmol)for three weeks. Subjects had normal salt diet in their daily routine life for the following 2 weeks.According to crossover nature of the study, the group had low salt diet (50mmol) at the last 3 weeks of the study.

Low salt diet

EXPERIMENTAL

The group had low salt diet (50mmol)for three weeks. Subjects had normal salt diet in their daily routine life for the following 2 weeks.According to crossover nature of the study, the group had normal salt diet at the last 3 weeks of the study.

Behavioral: Lowering salt in diet

Interventions

Lowering salt in diet BEHAVIORAL

Low salt diet (50mmol)for three weeks.

Low salt diet

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects who are 50 years and older
• Subjects whose systolic blood pressure is ≥ 140 mmHg
• Subjects whose diastolic blood pressure is ≥ 90 mmHg
• Subjects who is normal weighted defined as body mass index \< 25 or who is obese defined as body mass index \> 30
• Subjects who have intellectual capacity to adapt diets and 24 hour urine collection
• Informed about the study and consented to include the study

You may not qualify if:

• Known heart failure
• Known renal failure
• Known chronic liver disease
• Antihypertensive drug use
• nonsteroidal anti inflammatory (NSAI) drug use

Sponsors & Collaborators

• Turkish Society of Hypertension and Renal Diseases: lead

MeSH Terms

Conditions

Hypertension

Interventions

Diet

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Mustafa Arici, Prof.

  Hacettepe University Faculty of Medicine Department of Nephrology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2012
• First Posted: June 26, 2012
• Study Start: March 1, 2011
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: June 26, 2012

Record last verified: 2011-08